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Hypnosis vs Midazolam for Sedation for TEE

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT01749475
First received: December 12, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

Most of the reports on hypnosis in the literature have focused on pain control during minor operations. With this study we aimed to evaluate the role of hypnosis on sedation for transesophageal echocardiography and compare it with commonly used sedative midazolam.


Condition Intervention
Clinical Indications for Transesophageal Echocardiography
 Drug: Midazolam
Other: hypnotherapy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Hypnosis for Sedation in Transesophageal Echocardiography: Comparison With Midazolam

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:

Primary Outcome Measures:
  • Sedative effects of hypnotherapy and the drug "midazolam" indicated by anxiety scores and bispectral index (BIS) monitoring [ Time Frame: during transesophageal echocardiography ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • measurement of alertness after sedation with continuous performance test (CPT) [ Time Frame: the same time frame ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
midazolam Drug: Midazolam
The patients will be given 0.05mg/kg iv midazolam just before monitorization. During probing, in case of intolerance to the insertion of the probe, the increments of midazolam with 0.005mg/kg doses will be given.
hypnosis Other: hypnotherapy
A first hypnotic induction will be carried out the day before the procedure, next day, fifteen minutes before the procedure, a new induction will be performed.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients admitting to cardiology department for transesophageal echocardiography (TEE)

Criteria

Inclusion Criteria:

  • indications for TEE
  • American Society of Anesthesiology (ASA) physical status I-III

Exclusion Criteria:

  • mental illness,
  • psychotropic medication use,
  • hypersensitivity to drugs
  • a body mass index over 30.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749475

Locations
Turkey
Bakirkoy Dr Sadi Konuk Training Hospital
Istanbul, Turkey
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
  More Information

No publications provided

Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT01749475     History of Changes
Other Study ID Numbers: HYPTEE
Study First Received: December 12, 2012
Last Updated: February 27, 2013
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013